Shire announces Phase III trial for Cinryze (C1 esterase inhibitor human) to treat antibody mediated rejection in kidney transplant patients

Shire is planning a Phase III multi-centre, multi-national, randomised, double-blind, placebo-controlled study (SHP616-302) to evaluate the efficacy of Cinryze (C1 esterase inhibitor human, intravenous administration) as an adjunct to DSA (donor specific antibody) reduction therapy (plasmapheresis, plasma exchange, and/or immune adsorption treatments and IVIG) for the treatment of acute antibody mediated rejection (AMR) in kidney transplant recipients. The trial will be conducted in the United States, Europe and Canada and the study will open for enrolment by the end of October 2015.

AMR is a condition that sometimes occurs in patients following solid organ transplantation and is initiated by the presence of DSA in the transplant recipient. DSA identified prior to transplant (pre-formed) may be a contraindication to transplantation due to the risk of AMR, however DSA can also form after a transplant takes place. AMR can be life threatening and debilitating to the transplant recipient, often resulting in declining organ function and reduced graft survival.